MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 388928

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from a healthcare professional (hcp) via a manufacturer representative reported a problem occurred during implant procedure of the lead.The mandrel was positioned while the lead was bent at the end.It was visually noticed that the mandrel had passed between the pads and changed the electrode as a precaution.It was noted that the ¿chuck¿ of the electrode passed between contacts 0 and 1 during the procedure.There was no consequence and the lead was replaced by precaution.The issue was noted as resolved.

Manufacturer Narrative

Analysis of the lead, model 3889-28, found lead distal end electrode distal end bent.Analysis identified the electrode at the distal end of the lead was bent.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis identified the outer insulation of the lead was broken//torn under electrode #1.Analysis observed the distal end of the lead was stretched.Analysis observed the distal end of the lead was bent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that during the intervention, the surgeon introduced the electrode into the white dilator, then he mobilized the curved chuck in the electrode, the curved chuck then passed between contacts 0 and 1 of the electrode.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7020188
• MDR Text Key: 92059710
• Report Number: 2649622-2017-12851
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: 388928
• Device Catalogue Number: 388928
• Device Lot Number: VA1KC52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/01/2017; 12/20/2017
• Supplement Dates FDA Received: 12/06/2017; 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1